Clinical Study Management
At mediSMART, we provide end-to-end clinical study management services tailored to support sponsors throughout the entire trial lifecycle. Our experienced team ensures operational excellence by combining scientific insight, regulatory expertise, and streamlined processes.
Our Clinical Study Management services include:
📄 eCRF and ICF Design, Adaptation, and Implementation
We design and implement customized electronic Case Report Forms (eCRFs) and Informed Consent Forms (ICFs) that are aligned with global regulatory standards and tailored to protocol-specific needs. Our team ensures that forms are user-friendly, compliant, and optimized for high-quality data collection.
🧪 Local and Central Laboratory Organization
We coordinate local and central laboratory services, ensuring efficient sample logistics, standardized data reporting, and compliance with country-specific requirements. Our established lab networks and vendor oversight practices reduce delays and improve data consistency.
🎓 Study-Specific Trainings
We develop and deliver customized training programs for investigators, site staff, and study teams. Our trainings cover protocol procedures, GCP compliance, and system usage, empowering teams with the knowledge and tools they need for successful execution.
Medical Writing
Clear. Compliant. Scientifically Sound.
At mediSMART, our Medical Writing Services are designed to support sponsors and CROs throughout the entire clinical development lifecycle. From early-phase protocols to final study reports and regulatory submissions, we deliver accurate, high-quality, and submission-ready documents that meet global standards.
Our Services Include:
📄 Regulatory & Clinical Trial Documents
- Clinical Study Protocols & Amendments
- Investigator's Brochures (IBs)
- Clinical Study Reports (CSRs)
- Informed Consent Forms (ICFs)
- IMP Dossiers and Product Information Documents
📢 Scientific & Medical Communications
- Abstracts, Posters, and Slide Decks
- Manuscripts for peer-reviewed journals
- Literature reviews and publication support
- Medical content for educational or promotional use
📨 Submission & Compliance Documents
- Common Technical Document (CTD) modules
- Risk Management Plans and Safety Reports
- Briefing documents for regulatory agencies
- Responses to regulatory queries
Why mediSMART?
- ✅ Scientifically accurate
- ✅ Well-structured and clearly written
- ✅ Compliant with ICH-GCP and regional regulatory requirements
- ✅ Tailored to the target audience – whether regulatory agencies, investigators, or patients
We collaborate closely with clinical, regulatory, and safety teams to deliver content that drives understanding, supports decision-making, and ensures smooth progress of your clinical development programs.
Investigative Site Services
mediSMART partners closely with investigative sites to ensure clinical trials are conducted efficiently, compliantly, and with patient-centric focus. Our site support services are designed to strengthen operational performance at the site level and enhance enrollment outcomes.
Our Investigative Site Services include:
🏥 Site Feasibility and Selection Process
We conduct thorough feasibility assessments to identify high-performing, protocol-aligned sites. Our selection process is data-driven and considers site experience, patient availability, infrastructure, and regulatory readiness to ensure optimal site performance.
👁️ Monitoring Visits
Our experienced clinical research associates (CRAs) carry out regular on-site and remote monitoring visits to ensure protocol compliance, subject safety, and data integrity. We tailor monitoring strategies to fit each study's complexity and risk level.
👥 Subject Recruitment and Site Recruitment Support
We support both subject and site recruitment by developing targeted strategies to accelerate enrollment and minimize delays. From identifying recruitment challenges to implementing outreach plans, we help sites meet enrollment goals efficiently.
🔄 Subject Transfers
We facilitate smooth subject transfers between sites when needed, ensuring continuity of care, data accuracy, and regulatory compliance. Our team coordinates the logistics and documentation required for a seamless transition.
📑 Regulatory Services
Navigating the regulatory landscape is critical to the success of any clinical trial. At mediSMART, our regulatory experts manage submissions and approvals with precision, ensuring full compliance with local and international requirements throughout the study lifecycle.
Our Regulatory Services include:
🗂️ IRB/IEC and Competent Authority (CA) Initial Submissions & Approval Tracking
We prepare and submit comprehensive initial application packages to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Competent Authorities (CAs). We also provide ongoing tracking and communication to ensure timely approvals and mitigate delays.
📨 Regulatory Submissions and Follow-Up During the Study
From site activations to study updates, we manage all regulatory communications and submissions throughout the trial. Our team ensures that regulatory obligations are met consistently, and follow-ups are tracked and resolved efficiently.
✏️ Amendments and Annual Notifications
We handle protocol amendments, investigator brochure updates, and annual safety reports, ensuring that all changes are submitted to the appropriate authorities in a timely and compliant manner.
📦 Substantial Submissions
Our regulatory team is experienced in preparing and submitting substantial modifications and safety-related updates, maintaining alignment with country-specific guidelines and sponsor expectations.
Regulatory Services
Our Regulatory Services include:
🗂️ IRB/IEC and Competent Authority (CA) Initial Submissions & Approval Tracking
We prepare and submit comprehensive initial application packages to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Competent Authorities (CAs). We also provide ongoing tracking and communication to ensure timely approvals and mitigate delays.
📨 Regulatory Submissions and Follow-Up During the Study
From site activations to study updates, we manage all regulatory communications and submissions throughout the trial. Our team ensures that regulatory obligations are met consistently, and follow-ups are tracked and resolved efficiently.
✏️ Amendments and Annual Notifications
We handle protocol amendments, investigator brochure updates, and annual safety reports, ensuring that all changes are submitted to the appropriate authorities in a timely and compliant manner.
📦 Substantial Submissions
Our regulatory team is experienced in preparing and submitting substantial modifications and safety-related updates, maintaining alignment with country-specific guidelines and sponsor expectations.
SMO Services
Our SMO Services include:
👩⚕️ Recruitment of Site Staff for Clinical Sites
We handle the recruitment and onboarding of qualified site personnel, including study coordinators, nurses, and administrative staff. Our process ensures that the right people are placed quickly and compliantly, aligned with study needs.
📊 Reporting Based on the FTE Model
We provide transparent, FTE-based reporting to sponsors and CROs, enabling accurate budgeting, performance tracking, and resource planning throughout the study.
🗂️ Study Coordinator Management
Our team oversees daily operations and performance of study coordinators, ensuring consistent support for investigators and timely execution of trial activities.
💸 Patient Reimbursements
We manage end-to-end reimbursement processes for patient travel, meals, and other study-related expenses — enhancing retention and satisfaction through a smooth financial experience.
💊 Pharmacy Payment and Invoicing Procedures
mediSMART facilitates payment coordination with site pharmacies, including invoicing, payment tracking, and documentation management to ensure financial accuracy and regulatory compliance.
🔄 Revolving Fund Payments and Tracking
We administer Revolving Fund (RF) payment systems, ensuring timely fund disbursement, reconciliation, and ongoing tracking to support site sustainability and accountability.
🎓 Site Staff Trainings
Our tailored training programs for site staff cover protocol procedures, GCP compliance, regulatory updates, and site systems — supporting high-quality performance across all roles.
Data Management Services
At mediSMART, our data management services ensure accuracy, integrity, and regulatory compliance throughout the clinical data lifecycle. We apply robust planning, expert analysis, and validated systems to transform raw data into reliable insights that drive confident decision-making.
Our Data Management Services include:
💻 EDC Preparation and Guidelines
We manage the setup of Electronic Data Capture (EDC) systems, including guideline creation, user access configuration, and system validation — ensuring clean and timely data collection from study start to close-out.
📊 Design of Statistical Considerations
Our statisticians work closely with clinical teams to define key statistical parameters and endpoints, aligned with regulatory expectations and study objectives.
🔢 Sample Size Calculation
We provide precise sample size estimations based on the study design, expected treatment effect, variability, and power — helping sponsors optimize trial efficiency and statistical validity.
📝 Data Management Plan (DMP) Preparation
We develop comprehensive Data Management Plans, outlining all processes related to data handling, quality control, and timelines — ensuring smooth and consistent data operations.
✅ Data Validation Plan (DVP) Preparation
Our team creates Data Validation Plans to define edit checks, query logic, and data discrepancy processes — essential for data accuracy and regulatory readiness.
📈 Statistical Analysis Plan (SAP) Development
We prepare detailed Statistical Analysis Plans covering analysis populations, methods, and output specifications, ensuring alignment with the protocol and regulatory requirements.
🗄️ Database Generation and Data Entry Processes
We oversee custom database creation and data entry workflows, ensuring accuracy, traceability, and compatibility with regulatory standards.
📉 Statistical Analysis
Our expert statisticians perform in-depth statistical analyses using validated software and methodologies, delivering clear outputs for reporting and decision-making.
🎓 Data Management Trainings
We offer targeted training programs on data management systems, standards, and SOPs — empowering teams to maintain high-quality data throughout the study.
Contracts and Payments Services
mediSMART simplifies the complex financial and contractual aspects of clinical trials by offering end-to-end contract management and payment solutions. Our services ensure transparency, compliance, and efficiency for both sponsors and investigative sites.
Our Contracts and Payments Services include:
💰 Investigator and Institution Payments
We manage timely and accurate payments to investigators and institutions, aligned with milestone deliverables and contractual agreements — reducing administrative burden and ensuring satisfaction at the site level.
🔄 Revolving Fund Services
Our team provides full support for Revolving Fund (RF) management, including fund setup, disbursement, reconciliation, and reporting — helping sites operate without financial delays.
📑 IRB/IEC and Competent Authority (CA) Notification Payments
We coordinate and execute payment of regulatory submission fees to ethics committees and authorities, ensuring smooth regulatory processing and compliance with local requirements.
📊 Payment Tracking and Invoicing Processes
We implement transparent payment tracking systems and manage invoicing workflows for both sponsors and sites, ensuring clarity, traceability, and reduced risk of payment delays or discrepancies.
📝 Site Support for Clinical Trial Agreement (CTA) Execution
mediSMART provides expert guidance and operational support for the drafting, negotiation, and execution of Clinical Trial Agreements — helping align sponsor, CRO, and site expectations while minimizing turnaround time.
Equipment Supply and Calibrations
mediSMART ensures that your clinical trial sites are fully equipped and compliant by providing reliable equipment sourcing and calibration services. We supply and maintain high-quality equipment essential for clinical trial operations, with tracking and calibration processes designed to meet regulatory standards.
Our Equipment Services include:
🔧 Supply of Clinical Trial Equipment
We source and deliver a wide range of clinical trial equipment, including centrifuges, freezers, refrigerators, and ancillary supplies, tailored to study-specific needs and site requirements.
📏 Calibration Tracking and Performance
We manage the ongoing calibration and performance tracking of supplied equipment to ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines. Our service includes documentation, scheduling, and quality checks for audit readiness.